Associate Director, Analytical Product Lifecycle Management

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

Job Summary

Responsible for providing strategic directions to the staff and activities of AD-PLCM/MLCM laboratories at Signet and Etobicoke. Organizes and coordinates product development process in the team-based environment, provides guidance to scientists/chemists, implements team-oriented approach from the earlier stages to completion of the project. Evaluates technical data and decides on course of action during PLCM/MLCM process. Responsible for the quality of newly developed analytical methods as well as their validation to support the regulatory submissions of new API sources, and revision and validation of legacy methods to meet current global regulatory standards.

Job Responsibilities

• Plans and organizes the activities in the Analytical Development Product Life Cycle Management Team.
• Responsible for the quality of documentation and test results generated in Analytical-PLCM and MLCM.
• Responsible for providing analytical support for Technical Operation trial
• Establishes priorities and sets deadlines to meet overall PLCM/MLCM project
• Reviews and approves technical reports generated by the laboratory.
• Assigns projects to the staff, co-ordinates work, evaluates results and provides directions for course of action.
• Monitors the quality and productivity of the laboratory output to ensure that optimum levels are achieved. Makes recommendations to the Sr. Director for continuous improvement of laboratory operations.
• Ensure professional development of Identifies training needs for staff and initiates actions to ensure that all training needs are met.
• Responsible for the management of the Makes recommendations and justifications for promotions to the Sr. Director.
• Interviews, evaluates, and makes recommendations regarding candidates for
• Demonstrates corporate values in the performance of the work and interactions with
• Performs additional related duties, as assigned, in accordance with job responsibilities and necessary departmental objectives.
• Works closely with other units of AR&D QC, providing expert advice to other members of the team.
• Liaises across the organization at all levels to provide an in-depth level of
• Investigates, encourages and uses unconventional/unique problem-solving techniques to perform troubleshooting on highly complex issues with respect to the stability of drug substances and drug products, chromatographic methodology etc.
• Oversee the resolution of more complex issues related to
• Oversees resolution of all departmental issues with internal
• Contributes to the development of departmental contingency and emergency response
• Performs all work in accordance with all established regulatory, compliance and safety
• Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leaders while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as

Job Requirements

• Education
  • Advanced degree, preferably D. in a scientific discipline especially Organic Chemistry, Analytical Chemistry or Pharmaceutical Sciences
• Knowledge, Skills and Abilities
  • Advanced knowledge and understanding of the principles of solid-state chemistry, pharmaceutical solid dosage forms, in-vivo permeability, and biopharmaceutical issues.
  • Demonstrated technical proficiency, scientific creativity, teamwork, and independent thought process.
  • Excellent written and verbal communication
  • Leadership and supervisory skills demonstrated in previous supervisory/management roles.
  • Good understanding of pharmaceutical regulatory requirements regarding R&D international regulatory expertise is an asset.
• Experience
  • Not less than 5 years, preferably more, of pharmaceutical industry experience with demonstrated achievements in pharmaceutical R&D with focus on analytical

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

The hiring range for this position is $ 126,425.43- $ 176,425.43 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.

We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.

The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen, select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex.